Ischemic StrokeIMAGECATNCT03745391
Multimodal Neuroimaging in the Selection of Acute Ischemic Stroke (AIS) Patients to Endovascular Treatment (EVT)
A study testing MULTIMODAL MAGNETIC RESONANCE (Multimodal MR) and MULTIMODAL COMPUTERIZED TOMOGRAPHY (Multimodal CT) in people with Ischemic Stroke and Arterial Occlusion, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
To study the feasibility and usefulness of multimodal MR compared to multimodal CT to select patients with acute ischemic stroke and favorable clinical outcome after mechanical thrombectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Arterial Occlusion, CTS
- What is being tested?
- MULTIMODAL MAGNETIC RESONANCE (Multimodal MR) and MULTIMODAL COMPUTERIZED TOMOGRAPHY (Multimodal CT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteSpain
- Study dates
- 13 Nov 2018to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Without previous functional dependency evaluated by modified Rankin Score ≤2
- Regarding stroke severity (NIHSS≥ 6)
- Time from symptoms onset <24 hours
Who cannot join
- Clinical suspicion of vertebrobasilar occlusion (brainstem symptoms)
- MR contraindication or lack of concomitant availability of one or both neuroimaging techniques
- Severe kidney failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IMAGECAT Study: Multimodal Neuroimaging of Choice in the Selection of Patients With Acute Stroke and Favorable Clinical Response to Endovascular Treatment
To study the feasibility and usefulness of multimodal MR compared to multimodal CT to select patients with acute ischemic stroke and favorable clinical outcome after mechanical thrombectomy. The specific objectives are to compare (1) the door-picture time and door-groin puncture time, (2) the rate of patients with acute stroke selected for endovascular treatment and (3) the safety and clinical response after thrombectomy between the two groups selected according to the imaging modality.
Methodology: Single-center, randomized 1:1 and stratified by age and NIHSS study of consecutive patients with suspected acute ischemic stroke. Occlusion site, ischemic volume (core) and perfusion volume will be studied by an automated perfusion system (RAPID software) in both neuroimaging groups. Mechanical thrombectomy criteria will be basically based on the presence of a Large Vessel Occlusion (LVO) and a volume of core lower than 70cc in the Cerebral Blood Flow (CBF) or Diffusion Weighted Image (DWI) sequences. Modified Rankin scale at 90 days and the rate of intracranial hemorrhage and mortality will be considered as variables of response.
Read the detailed description
In acute ischemic stroke, arterial occlusion lead to a brain ischemia that will progress to brain death of the ischemic area if the clot is not rapidly removed. Advanced neuroimaging can help us to distinguish between the irreversible injury brain parenchyma or core and the potential reversible ischemic tissue or penumbra. Multimodal neuroimaging techniques (MR and CT) have been developed in order to distinguish between core and penumbra areas and have been used to select patients in most of the last randomized clinical trials that have demonstrated the benefit of endovascular treatment. There is no agreement about which multimodal technique offers a better information to select patients for endovascular treatment.
The main aim is to study the feasibility and usefulness of multimodal MR compared to multimodal CT to select patients with acute ischemic stroke and favorable clinical outcome after mechanical thrombectomy.
The specific objectives are: Primary: to confirm no differences in long-term clinical outcome in patients with acute ischemic stroke and in those treated with endovascular therapy selected by multimodal CT or MR; and Secondary: (1) compare the feasibility of both techniques in this setting, (2) the door-picture time and door-groin puncture time of both techniques, (3) the safety of both techniques (sICH and in-hospital pneumonia) Methodology: Single-center, randomized (1:1) and stratified by age and NIHSS study of consecutive patients with acute ischemic stroke. Occlusion site, ischemic volume (core) and perfusion volume will be studied by an automated perfusion system (RAPID software) in both neuroimaging groups. Mechanical thrombectomy criteria will be basically based on the presence of an intracranial LVO occlusion and a volume of core lower than 70cc in the CBF or DWI sequences. Modified Rankin scale at 90 days and the rate of intracranial hemorrhage and mortality will be considered as variables of response.
- Conditions
- Ischemic Stroke, Arterial Occlusion, CTS, Magnetic Resonance Imaging
- Being tested
- MULTIMODAL MAGNETIC RESONANCE (Multimodal MR), MULTIMODAL COMPUTERIZED TOMOGRAPHY (Multimodal CT)
- Medical subject headings
- Ischemic Stroke, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MULTIMODAL MAGNETIC RESONANCE (Multimodal MR)Diagnostic test
After randomization, a MULTIMODAL MR will be performed to select treatment patient
MULTIMODAL COMPUTERIZED TOMOGRAPHY (Multimodal CT)Diagnostic test
After randomization, a MULTIMODAL CT will be performed to select treatment patient
| Study group | Role | What they receive |
|---|---|---|
| MULTIMODAL MAGNETIC RESONANCE (MR) | Active comparator | Diagnostic test: Multimodal Neuroimaging Test: MR The group of patients with clinical suspicion of acute stroke and that fulfill the inclusion/exclusion criteria for the study that after randomization be assigned to Multimodal MR, will be directedly transferred to MR. It will be performed a multimodal MR taking into account that after discard an intracerebral haemorrhage and confirm an ischemic lesion if the patient fulfill criteria to receive intravenous alteplase, the test will be paused just to administer the treatment and immediately put again into the machine to complete the MR images. With all the information vascular neurologist will be decide if it is necessary administer endovascular treatment. Receives: Diagnostic Test: MULTIMODAL MAGNETIC RESONANCE (Multimodal MR) |
| MULTIMODAL COMPUTED TOMOGRAPHY (CT) | Active comparator | Diagnostic test: Multimodal Neuroimaging Test: CT The group of patients with clinical suspicion of acute stroke and that fulfill the inclusion/exclusion criteria for the study that after randomization is assigned to Multimodal CT, will be directedly transferred to CT. If the patient fulfill criteria to receive intravenous alteplase after discard an intracerebral haemorrhage the CT will be paused to administer the treatment and immediately will continue with the test. At the end of the test the vascular neurologist will decide if it is necessary administer endovascular treatment. Receives: Diagnostic Test: MULTIMODAL COMPUTERIZED TOMOGRAPHY (Multimodal CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate long-term clinical outcome in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
Modified Rankin Scale (mRS) ordinal distribution in each group. The mRS measures the patient functional status. It range from 0 to 6, and the values are (0, 1, 2, 3, 4, 5 and 6). The 0 value indicate a patient completely functional independent and without neurological deficit and 6 value indicate death. The value 1 indicate a minor neurological deficit but the patient is fully independent, the value 2 indicate that the patient do not perform all his activities (like work) but is fully independent for the daily activities so can live alone without assistance, value 3 indicates a patient partially dependent taht can not live alone during more than a week, value 4 indicates a patient totally dependent in a wheelchair but able to be some hours without assistance, and value 5 indicates a patient totally dependent in bed.
Measured: 90 days
Secondary outcomes (7)
To evaluate long-term good clinical outcome in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
Modified Rankin Scale (mRS<3) in each group. The mRS measures the patient functional status. It range from 0 to 6, and the values are (0, 1, 2, 3, 4, 5 and 6). The 0 value indicate a patient completely functional independent and without neurological deficit and 6 value indicate death. The value 1 indicate a minor neurological deficit but the patient is fully independent, the value 2 indicate that the patient do not perform all his activities (like work) but is fully independent for the daily activities so can live alone without assistance, value 3 indicates a patient partially dependent taht can not live alone during more than a week, value 4 indicates a patient totally dependent in a wheelchair but able to be some hours without assistance, and value 5 indicates a patient totally dependent in bed.
Measured: 90 days
To evaluate the rate of symptomatic intracerebral haemorrhage in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
To compare the rate of symptomatic intracranial haemorrhage
Measured: 24-36 hours after stroke
To evaluate mortality in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
To compare mortality at 7 days and 90 days
Measured: 7-90 days after stroke
To evaluate the presence of vomiting during the acquisition technique in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
To compare vomiting during the acquisition technique time
Measured: At 24 hours after stroke
To evaluate the presence of in-hospital pneumonia in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
To compare the rate of in-hospital pneumonia
Measured: During hospitalization after stroke (approximately 7 days)
Indication of EVT in each technique
Rate of ischemic stroke patients selected for endovascular treatment by each technique
Measured: Through study completion, approximately 1 year
Feasibility of multimodal neuroimaging to select patients for EVT
Door-picture time and door-groin puncture time in each technique and movement artifacts
Measured: Through study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start13 Nov 2018
- Primary completion15 Jun 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be included consecutively and randomized (1:1) to Multimodal MR or Multimodal CT stratifying by age (\<70, ≥70), stroke severity (NIHSS\<18, ≥18) and time from onset to hospital (\<8 hours, ≥8 hours)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Millan Torne, Germans Trias i Pujol Hospital
- Investigators
- Meritxell Gomis, MD PhD, Study chair, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745391
- Sponsor's protocol ID
- Hospital Germans Trias i Pujol
- Acronym
- IMAGECAT
- Status last verified
- Jun 2022
- First submitted
- 28 May 2018
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMAGECAT Study: Multimodal Neuroimaging of Choice in the Selection of Patients With Acute Stroke and Favorable Clinical Response to Endovascular Treatment
- ClinicalTrials.gov ID
- NCT03745391
- Acronym / sponsor ID
- IMAGECAT / Hospital Germans Trias i Pujol
- Conditions
- Ischemic Stroke, Arterial Occlusion, CTS, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the feasibility and usefulness of multimodal MR compared to multimodal CT to select patients with acute ischemic stroke and favorable clinical outcome after mechanical thrombectomy. The specific objectives are to compare (1) the door-picture time and door-groin puncture time, (2) the rate of patients with acute stroke selected for endovascular treatment and (3) the safety and clinical response after thrombectomy between the two groups selected according to the imaging modality.
Methodology: Single-center, randomized 1:1 and stratified by age and NIHSS study of consecutive patients with suspected acute ischemic stroke. Occlusion site, ischemic volume (core) and perfusion volume will be studied by an automated perfusion system (RAPID software) in both neuroimaging groups. Mechanical thrombectomy criteria will be basically based on the presence of a Large Vessel Occlusion (LVO) and a volume of core lower than 70cc in the Cerebral Blood Flow (CBF) or Diffusion Weighted Image (DWI) sequences. Modified Rankin scale at 90 days and the rate of intracranial hemorrhage and mortality will be considered as variables of response.
Detailed description
In acute ischemic stroke, arterial occlusion lead to a brain ischemia that will progress to brain death of the ischemic area if the clot is not rapidly removed. Advanced neuroimaging can help us to distinguish between the irreversible injury brain parenchyma or core and the potential reversible ischemic tissue or penumbra. Multimodal neuroimaging techniques (MR and CT) have been developed in order to distinguish between core and penumbra areas and have been used to select patients in most of the last randomized clinical trials that have demonstrated the benefit of endovascular treatment. There is no agreement about which multimodal technique offers a better information to select patients for endovascular treatment.
The main aim is to study the feasibility and usefulness of multimodal MR compared to multimodal CT to select patients with acute ischemic stroke and favorable clinical outcome after mechanical thrombectomy.
The specific objectives are: Primary: to confirm no differences in long-term clinical outcome in patients with acute ischemic stroke and in those treated with endovascular therapy selected by multimodal CT or MR; and Secondary: (1) compare the feasibility of both techniques in this setting, (2) the door-picture time and door-groin puncture time of both techniques, (3) the safety of both techniques (sICH and in-hospital pneumonia) Methodology: Single-center, randomized (1:1) and stratified by age and NIHSS study of consecutive patients with acute ischemic stroke. Occlusion site, ischemic volume (core) and perfusion volume will be studied by an automated perfusion system (RAPID software) in both neuroimaging groups. Mechanical thrombectomy criteria will be basically based on the presence of an intracranial LVO occlusion and a volume of core lower than 70cc in the CBF or DWI sequences. Modified Rankin scale at 90 days and the rate of intracranial hemorrhage and mortality will be considered as variables of response.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be included consecutively and randomized (1:1) to Multimodal MR or Multimodal CT stratifying by age (<70, ≥70), stroke severity (NIHSS<18, ≥18) and time from onset to hospital (<8 hours, ≥8 hours)
| Arm | Type | Receives |
|---|---|---|
| MULTIMODAL MAGNETIC RESONANCE (MR) | Active comparator | Diagnostic Test: MULTIMODAL MAGNETIC RESONANCE (Multimodal MR)Diagnostic test: Multimodal Neuroimaging Test: MR The group of patients with clinical suspicion of acute stroke and that fulfill the inclusion/exclusion criteria for the study that after randomization be assigned to Multimodal MR, will be directedly transferred to MR. It will be performed a multimodal MR taking into account that after discard an intracerebral haemorrhage and confirm an ischemic lesion if the patient fulfill criteria to receive intravenous alteplase, the test will be paused just to administer the treatment and immediately put again into the machine to complete the MR images. With all the information vascular neurologist will be decide if it is necessary administer endovascular treatment. |
| MULTIMODAL COMPUTED TOMOGRAPHY (CT) | Active comparator | Diagnostic Test: MULTIMODAL COMPUTERIZED TOMOGRAPHY (Multimodal CT)Diagnostic test: Multimodal Neuroimaging Test: CT The group of patients with clinical suspicion of acute stroke and that fulfill the inclusion/exclusion criteria for the study that after randomization is assigned to Multimodal CT, will be directedly transferred to CT. If the patient fulfill criteria to receive intravenous alteplase after discard an intracerebral haemorrhage the CT will be paused to administer the treatment and immediately will continue with the test. At the end of the test the vascular neurologist will decide if it is necessary administer endovascular treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Without previous functional dependency evaluated by modified Rankin Score ≤2
- Regarding stroke severity (NIHSS≥ 6)
- Time from symptoms onset <24 hours
Key exclusion criteria (3 listed)
- Clinical suspicion of vertebrobasilar occlusion (brainstem symptoms)
- MR contraindication or lack of concomitant availability of one or both neuroimaging techniques
- Severe kidney failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MULTIMODAL MAGNETIC RESONANCE (Multimodal MR)After randomization, a MULTIMODAL MR will be performed to select treatment patient | Diagnostic test | MULTIMODAL MAGNETIC RESONANCE (MR) |
| MULTIMODAL COMPUTERIZED TOMOGRAPHY (Multimodal CT)After randomization, a MULTIMODAL CT will be performed to select treatment patient | Diagnostic test | MULTIMODAL COMPUTED TOMOGRAPHY (CT) |
Primary outcome
To evaluate long-term clinical outcome in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
Time frame: 90 days
Modified Rankin Scale (mRS) ordinal distribution in each group. The mRS measures the patient functional status. It range from 0 to 6, and the values are (0, 1, 2, 3, 4, 5 and 6). The 0 value indicate a patient completely functional independent and without neurological deficit and 6 value indicate death. The value 1 indicate a minor neurological deficit but the patient is fully independent, the value 2 indicate that the patient do not perform all his activities (like work) but is fully independent for the daily activities so can live alone without assistance, value 3 indicates a patient partially dependent taht can not live alone during more than a week, value 4 indicates a patient totally dependent in a wheelchair but able to be some hours without assistance, and value 5 indicates a patient totally dependent in bed.
7 secondary outcomes
To evaluate long-term good clinical outcome in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
Time frame: 90 days
To evaluate the rate of symptomatic intracerebral haemorrhage in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
Time frame: 24-36 hours after stroke
To evaluate mortality in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
Time frame: 7-90 days after stroke
To evaluate the presence of vomiting during the acquisition technique in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
Time frame: At 24 hours after stroke
To evaluate the presence of in-hospital pneumonia in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique
Time frame: During hospitalization after stroke (approximately 7 days)
Indication of EVT in each technique
Time frame: Through study completion, approximately 1 year
Feasibility of multimodal neuroimaging to select patients for EVT
Time frame: Through study completion, approximately 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meritxell Gomis, MD PhD study chair
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MULTIMODAL MAGNETIC RESONANCE (Multimodal MR) and MULTIMODAL COMPUTERIZED TOMOGRAPHY (Multimodal CT) in people with Ischemic Stroke and Arterial Occlusion, run by Germans Trias i Pujol Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate long-term clinical outcome in ischemic stroke patients, and those treated with EVT and selected by each multimodal technique (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.